Pulmotil Granular Premix 200 gkg

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
06-09-2022

Aktīvā sastāvdaļa:

TILMICOSIN PHOSPHATE

Pieejams no:

ELANCO MALAYSIA SDN BHD

SNN (starptautisko nepatentēto nosaukumu):

TILMICOSIN PHOSPHATE

Vienības iepakojumā:

10.00 mcg/mL

Ražojis:

TriRx Speke Limited

Produkta apraksts

                                LOT No:
DOM:
EXPIRY:
AF0472
_Pulmotil Granular Premix 200_
_g/kg_
Granular medicated premix for the preparation of medicated animal feed
Net Weight: 10 kg
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
JAUHI UBAT DARI KANAK -KANAK
ACTIVE DRUG INGREDIENT:
200g per kg Tilmicosin (as the phosphate).
PRODUCT DESCRIPTION:
A yellowish tan to reddish tan free-flowing granular material
consisting of tilmicosin phosphate on ground corn cobs.
PHARMACODYNAMICS:
Tilmicosin is a semi-synthetic macrolide antibiotic developed for the
effective control and treatment of swine pneumonia associated with
Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae and
Pasteurella multocida. The in vitro spectrum of activity is primarily
against gram-positive and certain gram-negative bacteria and
Mycoplasma sp. Generally, gram-negative enteric bacteria have not been
sensitive to tilmicosin.
PHARMACOKINETICS:
Absorption: When administered to pigs via the oral route at a dose of
400 mg tilmicosin/kg feed (equivalent to approximately 21.3 mg
tilmicosin/kg bodyweight/day), tilmicosin moves rapidly out of the
serum into areas of low pH. The highest concentration in the serum
(0.23±0.08 μg/ml) was recorded on day 10 of medication, but
concentrations above the limit of quantification (0.10 μg/ml) were
not found
in 3 out of 20 animals examined. Lung concentrations increased rapidly
between days 2 and 4, but no significant changes were obtained
following four days of dosing. The maximum concentration in lung
tissue (2.59±1.01 μg/ml) was recorded on day 10 of medication.
When administered at a dose of 200 mg tilmicosin/kg feed (equivalent
to approximately 11.0 mg/kg/day), plasma concentrations above the
limit of quantification (0.10 μg/ml) were found in 3 out of 20
animals examined. Quantifiable levels of tilmicosin were found in lung
tissue with
the maximum concentration (1.43±1.13 μg/ml) being recorded on day 10
of medication.
Distribution: Following oral administration, tilmicosin is distributed
throughout the body, but especially 
                                
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